Efficacy and Safety of Topical Statin Eye Drop in the Management of Dry Eye Associated With Meibomian Gland Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from tear break up time at week 12 follow up
研究概览
简要总结
In the first stage, to evaluate the safety of the topical medication produced by Sina Pharmaceuticals, this medication is experimentally tested on 10 volunteer patients. If no side effects occur, eligible patients are enrolled in the study after examination by a specialist. The second stage is a randomized, double-blind clinical trial, during which selected patients are randomly assigned to the control and intervention groups.
For patients in the intervention group, in addition to standard treatment, including eyelid hygiene and the use of artificial tears, a topical drop of Atorvastatin (50 microM) will be administered, one drop eight times a day in both eyes. In the control group, a placebo will be used in the same manner. The patients will be unaware of their assigned group.
Clinical examinations, including Schirmer's test, tear breakup time, fluorescein staining, and completion of the dry eye syndrome questionnaire and dry eye questionnaire, will be conducted before and after the intervention to assess the level of eye dryness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>20 years old
- •Dry eye induced by Meibomian gland dysfunction
- •Tear break up time less than 10 seconds
排除标准
- •Hematologic disorders
- •Coagulopathies
- •Use of anticoagulant medication
- •Use of Peptic ulcer disease
- •History of ocular surgeries in the last 3 months
- •History of any ocular Malignancies
- •History of ocular trauma
- •History of statin use
研究组 & 干预措施
Statin eye drop
Use of topical atorvastatin eye drop 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
干预措施: Statin eye drop (Drug)
Control
Use of topical eye drops as a placebo same as intervention group but without active ingredient of atorvastatin 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Change from tear break up time at week 12 follow up
时间窗: Baseline and week 12 follow up
Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 12 follow up after completion of prescription period (8 week)
Change from tear break up time at week 4 follow up
时间窗: Baseline and week 4 follow up
Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 4 follow up after completion of prescription period (8 week)
Change from tear break up time at week 8 follow up
时间窗: Baseline and week 8 follow up
Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 8 follow up after completion of prescription period (8 week)
次要结局
- Change from Ocular Surface Disease Index at week 4 follow up(Baseline and week 4 follow up)
- Change from Ocular Surface Disease Index at week 8 follow up(Baseline and week 8 follow up)
- Change from Ocular Surface Disease Index at week 12 follow up(Baseline and week 12 follow up)
- Change from dry eye score at week 4 follow up(Baseline and week 4 follow up)
- Change from dry eye score at week 8 follow up(Baseline and week 8 follow up)
- Change from dry eye score at week 12 follow up(Baseline and week 12 follow up)
研究者
Mohammadali Javadi, MD
Head of Ophthalmic Research Center
Shahid Beheshti University of Medical Sciences